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Delivra Files Provisional Patent for Berberine Product

Delivra Corp. (DVA.V) has successfully completed its first phase preclinical research into transdermal berberine for the prevention and treatment of cardiovascular disease related to high cholesterol and triglyceride levels.

Berberine is a natural plant extract that has been used in eastern medicine for thousands of years, and more recently also in the western world. There is an abundance of research on berberine, and its effectiveness in reducing cholesterol and triglycerides is well-established. The main challenges with the use of berberine in its traditional oral format are exceptionally low bioavailability (< 2%) and highly adverse gastrointestinal events. Transdermal berberine from Delivra overcomes these challenges, showing 8-times higher concentration levels in the blood than oral, with no gastrointestinal side effects, and proved significantly more effective than oral in reducing cholesterol and triglycerides in a model of metabolic disease. This achievement represents a first-in-class platform that may prove effective in reducing cholesterol, triglycerides, and other hallmarks of cardiovascular disease.

Delivra's research and development includes formulations, compounding, stability testing, and measurement of systemic penetration and delivery of topical berberine and the closely related natural product, dihydroberberine (DHB). Delivra-berberine and Delivra-DHB achieve circulating blood levels 8-times higher than an oral equivalent treatment, which overcomes a key limitation of this natural compound. With increased berberine blood levels is an expected increase in this compound's effectiveness to reduce cholesterol and triglyceride levels, with Delivra-DHB achieving a profound reduction in cholesterol by 34% and reduction in triglycerides by 85%, as compared to control. While this is pre-clinical data, it is very promising in the context of published rates for leading statin drugs in the range of 20-35% reduction in cholesterol and 10-30% reduction in triglycerides.

In certain cases, this treatment may provide a natural alternative to the use of statin drugs, the most prescribed drug class in the world, and most commonly recognized by the trade names Lipitor{A &#153;} (Pfizer Inc.), Zocor{A &#153;} (Merck & Co. Inc.), and Crestor{A &#153;} (Astra Zeneca Limited). A Delivra berberine therapy could avoid the side effects associated with statin drugs, including muscle pain, liver damage, stomach upset, increased blood sugar, and a range of neurological issues. Interestingly, preliminary data suggests the Delivra transdermal berberine may also function synergistically to enhance the performance of statin drugs, potentially allowing greater benefits while taking less drug.

"These strong results demonstrate the potential for a break-through natural product to address a globally prevalent health issue," said Dr. Joe Gabriele, founder and CEO of Delivra. "To bring to market a natural product that works as well or better than some of the world's most commonly prescribed drugs, without the side effects, would be a game changer for the treatment of cardiovascular disease. We will continue to advance our research, through further pre-clinical work and then into clinical trials, and we look forward to continuing to report to shareholders on our progress."

Delivra has filed a provisional US patent to protect its unique berberine formulations.

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